Comparing the Effectiveness of 2 Diets for Patients With Irritable Bowel Syndrome

This study is currently recruiting participants.
Verified December 2013 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Shanti Eswaran, University of Michigan
ClinicalTrials.gov Identifier:
NCT01624610
First received: June 18, 2012
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

The purpose of the study is to find out if the diets often recommended for patients with Irritable Bowel Syndrome with diarrhea (IBS-D) provide adequate relief. The study will compare two diets that are used to treat IBS-D symptoms to see which one is more effective. The study will also measure the effect of these diets on the bowel flora, which are the good bacteria that inhabit the bowels in healthy people.


Condition Intervention
Irritable Bowel Syndrome
Other: Dietary intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing the Effectiveness of Two Diets to Control the Symptoms of Irritable Bowel Syndrome With Diarrhea (IBS-D): a Randomized, Controlled Trial and Gastrointestinal Microbiome Analysis

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Proportion of patients with adequate relief. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Compare the proportion of patients with irritable bowel syndrome (IBS-D) reporting adequate relief on Diet 1 v Diet 2.


Secondary Outcome Measures:
  • Composite endpoint [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Composite endpoint: A responder will report a ≥30% reduction in mean daily abdominal pain score and a decrease in mean daily BSFS value of ≥1 compared to baseline for ≥2 of 4 treatment weeks. The proportion of responders between the 2 groups will be compared.

  • Abdominal Pain [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    An abdominal pain responder will report a ≥30% reduction in mean daily abdominal pain score compared to baseline for ≥2 of 4 treatment weeks. The proportion of responders between the two groups will be compared. Between group differences in the proportion of patients with a ≥30% reduction in mean daily abdominal pain score compared to baseline at the end of each treatment week will also be assessed.

  • Stool consistency [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    For stool consistency, a responder will be defined as one who reports a decrease in mean daily BSFS value of 1 or more compared to baseline for ≥2 of 4 treatment weeks. The proportion of responders between the 2 groups will be compared. Between group differences in the proportion of patients with a decrease in BSFS value of ≥1 compared to baseline at the end of each treatment week will also be assessed.

  • Stool frequency [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The number of bowel movements will be recorded each day by IVRS. The change from baseline in mean daily stool frequency for each treatment week will be compared for the two groups.

  • Individual symptoms [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The change from baseline in daily NRS scores averaged over each treatment week for abdominal discomfort, urgency, bloating, and fatigue will compared between the 2 groups.

  • Quality of life measures [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    IBS-Quality of Life scores, Hospital Depression Anxiety Scores, Work Productivity and Activity Impairment questionnaire, and Sleep Assessment questionnaires will be compared between groups before and after the dietary intervention.

  • Stool Microbiome [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    The effect of these 2 diets on the gut microbiome (number and species) in the context of IBS is not known. A change in the microbiota may be a mechanism through which symptom response is mediated.

    We will be measuring the shift in the relative abundance (richness) and variety (diversity) of gut microbial taxa in patients with irritable bowel syndrome (IBS-D) in response to dietary intervention. Stool microbiome would be collected and analyzed using the PhyloChip™ Assay (Second Genome Inc., San Bruno, CA).


  • Serum Biomarker Panel [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Recent attempts have been made to identify a serological biomarker profile (Prometheus Therapeutics & Diagnostics, San Diego, CA) which accurately identifies patients with IBS. We intend to perform a biomarker test panel at enrollment in all study subjects to assess whether specific combinations of biomarkers can positively or negatively predict response to either diet.


Estimated Enrollment: 100
Study Start Date: July 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Diet 1
Patients randomized to this arm will receive both written and face-to-face advice about how the components of Diet 1 can be used to control their IBS symptoms.
Other: Dietary intervention
After a 14 day screening period, subjects will be randomized to 1 of 2 diets to treat their IBS symptoms. They will receive dietary instruction and are expected to remain on this diet for 4 weeks.
Active Comparator: Diet 2
Patients randomized to this arm will receive both written and face-to-face advice about how the components of Diet 2 can be used to control their IBS symptoms.
Other: Dietary intervention
After a 14 day screening period, subjects will be randomized to 1 of 2 diets to treat their IBS symptoms. They will receive dietary instruction and are expected to remain on this diet for 4 weeks.

Detailed Description:

As irritable bowel syndrome (IBS) symptoms are often refractory to conventional therapies, there has been increasing interest in the role of diet in IBS. Certain foods may exacerbate symptoms of IBS. Thus, restricted diets have recently gained attention for the treatment IBS. The mechanism by which symptoms are improved is unclear, but these diets may improve symptoms by exerting changes on the GI microbiome.

Aims:

Primary Objective:

-Compare the proportion of patients with irritable bowel syndrome (IBS-D) reporting adequate relief on Diet 1 vs Diet 2

Secondary Objectives:

  • Assess the effects of these diets in patients with diarrhea-predominant IBS on the gastrointestinal microbiota and blood based biomarkers.
  • Compare the efficacy of Diet 1 vs Diet 2 in patients with diarrhea-predominant IBS on pre-specified clinical and quality of life endpoints.

Methods:

This is a prospective randomized control trial of adults meeting the Rome III criteria for irritable bowel syndrome with diarrhea (IBS-D). After a 2 week screening period and randomization, during which the severity of symptoms will be assessed and eligibility determined, patients will be randomized to Diet 1 vs Diet 2 for a period of 4 weeks.

The primary endpoint will be a comparison of the proportion of patients in each group reporting adequate relief of their IBS symptoms. For the secondary clinical outcomes, a responder definition incorporating abdominal pain and stool consistency as proposed by the FDA will be utilized. Key IBS-D symptoms will be assessed daily and adequate relief of IBS-D symptoms will be assessed weekly during the randomization period. We will also determine if a difference can be detected with high probability in the relative abundance and variety of specific bacterial taxa between the two groups before and after the 4 week dietary intervention. In addition, blood samples will be collected before and after randomization to measure relevant biomarkers of immune activation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meet Rome III criteria for IBS as assessed by a gastroenterologist:
  • Fulfill the Rome III stool consistency criteria for IBS -D
  • Willingness to maintain a stable dosage of IBS medications during the pretreatment baseline period, including tricyclic antidepressants; "rescue" medications permitted (ie Loperamide 2mg up to 4 times per day prn diarrhea)
  • Ability to provide written informed consent for study participation
  • Capable of independently completing all requirements of the study including returning for required visits
  • Documentation of normal colonoscopy with colon biopsies within five years
  • Documentation of normal TSH, CBC, electrolyte panel
  • Negative evaluation for celiac disease either with normal TTG, EMA, and/or duodenal biopsy.

Exclusion Criteria:

  • Unable to understand or provide written informed consent
  • Pregnancy
  • IBS with constipation or mixed subtype
  • Comorbid medical problems that may affect gastrointestinal transit or motility:
  • Inflammatory bowel disease
  • Extraintestinal disease known to affect the gastrointestinal system (ie, scleroderma, unstable thyroid disease, diabetes mellitus, etc.)
  • Severe renal or hepatic disease
  • Previous abdominal surgery other than appendectomy, cholecystectomy, and gynecologic/urologic surgery
  • Previous treatment with some diets for IBS
  • Concurrent medications not permitted including probiotics, antibiotics, and narcotics
  • Active participation in another form of dietary therapy
  • Patients who have undergone surgery to the GI tract except appendectomy or cholecystectomy if performed more than six months prior to enrollment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01624610

Contacts
Contact: Shanti L Eswaran, MD 7349364785 seswaran@med.umich.edu
Contact: Lina Nahlawi 734-936-2761 lnahlawi@med.umich.edu

Locations
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Robert Siwiec, MD    317-948-5136    rsiwiec@iu.edu   
Contact: Anita Gupta, MPH    317.948.9227    anigupta@iupui.edu   
Principal Investigator: Robert Siwiec, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Shanti L Eswaran, MD    734-936-6400    seswaran@med.umich.edu   
Contact: Lina Nahlawi, MPH    734-936-2761    lnahlawi@med.umich.edu   
Principal Investigator: Shanti Eswaran, MD         
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Shanti L Eswaran, MD University of Michigan
  More Information

No publications provided

Responsible Party: Shanti Eswaran, Clinical Lecturer, University of Michigan
ClinicalTrials.gov Identifier: NCT01624610     History of Changes
Other Study ID Numbers: UMGI-DIETIBS
Study First Received: June 18, 2012
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Irritable bowel syndrome
Diarrhea
abdominal pain
diet
nutrition

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 21, 2014